NCT04401202

Nigella Sativa in COVID-19

Effects of Nigella Sativa as a Treatment of Patients With Upper Respiratory Tract Infection Caused by SARS-coronavirus-2: a Prospective, Randomized, Open-label, Controlled Clinical Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nigella sativa oil	Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Timeline

• Start date: 2020-05-21
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-05-26
• Last updated: 2021-05-26
• Results posted: 2021-05-26

Locations

1 site across 1 country: Saudi Arabia